Clinical trial monitoring
CTSI's Clinical Trial Monitors, also referred to as Clinical Research Associates (CRAs), provide routine monitoring throughout the conduct of a clinical research study to help ensure compliance with Good Clinical Practice (GCP) guidelines, Food and Drug Administration (FDA) regulations, and University guidelines for clinical trials for all U of M investigator-initiated studies, regardless of funding source.
- The rights and well-being of participants are protected
- Reported trial data are accurate, complete, and verifiable from source documents
- The conduct of a trial is in compliance with the currently approved protocol, GCP, and applicable regulatory requirements
- Data integrity and participant safety data are accurately reported
- Compliance with good clinical practices (GCPs), FDA regulations (21 CFR 312 and 812), and university policies on research as applicable
Note: Clinical Trial Monitors review IND/IDE clinical trial studies occurring at the University of Minnesota. Monitors do not travel to other sites and do not perform monitoring for affiliate sites in multi-site studies.
Associated fees and funding for services
There are no fees for monitoring services provided for investigator-initiated studies for investigators with a U of M appointment.
Contact us to coordinate access to office hours:
- Available during regular business hours